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1.
J Acquir Immune Defic Syndr ; 91(S1): S16-S19, 2022 10 01.
Статья в английский | MEDLINE | ID: covidwho-2063113

Реферат

BACKGROUND: Some inpatients with HIV-RNA ≥500,000 copies/mL in China need to use 2-drug regimen for some reasons, although limited data are available for dolutegravir plus lamivudine (3TC) in those patients with ultra-high viral loads. METHODS: We conducted a single-center retrospective-prospective study in China and enrolled 42 ART-naive HIV-infected inpatients who use a once-daily 2-drug regimen because of various reasons (drug interaction, renal impairment, age, and other related comorbidities).They were divided into 2 groups, low viral load group (baseline viral load <500,000 copies/mL, n = 20) and high viral load group (baseline viral load ≥500,000 copies/mL, n = 22). All patients were followed up for 48 weeks. RESULTS: The median of baseline viral load was 5.74 log10 copies/mL and CD4+ T-cell count was 59 cells/µL. At week 48, there was no significant difference (P = 0.598) in proportions of participants with HIV-1 RNA <50 copies/mL [90%, 95% confidence interval (CI) (75.6% to 104.4%) in low viral load groups vs 95.5%, 95% CI (86.0% to 104.9%) in high viral load groups]. No differences were found in mean increase of CD4+ T-cell count from baseline between 2 groups (218 ± 122 vs 265 ± 127 cells/µL, P = 0.245). There is no grade 3 or higher treatment-related adverse events and none discontinued treatment because of adverse events. CONCLUSIONS: The results of our study in real world support dolutegravir + 3TC dual regimen as a promising therapy option for treatment-naive HIV-infected patient with baseline viral load ≥500,000 copies/mL.


Тема - темы
Anti-HIV Agents , HIV Infections , HIV Seropositivity , HIV-1 , Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Seropositivity/drug therapy , HIV-1/genetics , Heterocyclic Compounds, 3-Ring , Humans , Lamivudine/therapeutic use , Oxazines , Piperazines , Preliminary Data , Prospective Studies , Pyridones , RNA, Viral , Retrospective Studies , Viral Load
3.
Minerva Med ; 113(4): 695-706, 2022 Aug.
Статья в английский | MEDLINE | ID: covidwho-1975625

Реферат

BACKGROUND: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-related disease (COVID-19) is an infectious disease characterized by systemic inflammation, which might enhance baseline thrombotic risk, especially in hospitalized patients. Little is, however, known about predictors of thrombotic complications in patients with COVID-19. METHODS: We prospectively followed up 180 hospitalized COVID-19 patients. Demographics, clinical and laboratory features at presentation and past medical history were tested as predictors of the first thrombotic complication through multivariate Cox regression analysis and a categorical score generated based on the results. RESULTS: Sixty-four thromboses were recorded in 54 patients, of whom seven with thrombosis on admission and 47 with thrombosis during hospitalization. Patients with thrombosis were mainly Caucasian and diabetic, had marked baseline signs of inflammation and organ damage, lower PaO2/FiO2 ratio, higher D-dimer levels and history of major hemorrhages. The latter three variables were independently associated to thrombotic complications and concurred to a 0-5 score, which accounted for 80% of the total sample variability. Patients with three or more points of the newly generated score were at higher risk for thrombotic complications (HR=4.9, P<0.001). Patients with thrombotic complications were more likely to be admitted to intensive care and/or to die (HR=1.9, P=0.036). Five of 180 patients were diagnosed with disseminated intravascular coagulation and three of them died. Eleven minor and no major bleeding events were observed. CONCLUSIONS: Patients with COVID-19 are at increased risk for thrombosis and might be stratified on admission based on lower Pao2/FiO2 ratio, higher D-dimer levels and history of major hemorrhages.


Тема - темы
COVID-19 , Thromboembolism , Thrombosis , Algorithms , COVID-19/complications , COVID-19/epidemiology , Hemorrhage , Humans , Inflammation , Preliminary Data , SARS-CoV-2 , Thromboembolism/epidemiology , Thromboembolism/etiology , Thrombosis/epidemiology , Thrombosis/etiology
4.
Clin Rheumatol ; 41(10): 3199-3209, 2022 Oct.
Статья в английский | MEDLINE | ID: covidwho-1906098

Реферат

BACKGROUND/OBJECTIVE: To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry. METHODS: SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed. RESULTS: A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%), and spondyloarthritis (12.3%). Most of them were in remission (28.5%) or low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid treatment, 35.7% methotrexate, 29.7% biological (b) disease modifying anti-rheumatic drugs (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19. CONCLUSIONS: In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points • This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. • A quarter of the patients presented an adverse event. The incidence of adverse events was significantly higher in those receiving mRAN-1273 and ChAdOx1 nCoV-19. • In this cohort, 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.


Тема - темы
COVID-19 Vaccines , COVID-19 , Adult , Aged , Antirheumatic Agents/therapeutic use , Argentina/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Female , Glucocorticoids , Humans , Janus Kinase Inhibitors , Male , Methotrexate , Middle Aged , Preliminary Data , RNA, Messenger , Registries , SARS-CoV-2 , Vaccination , Vaccines, Inactivated
5.
Arch Argent Pediatr ; 120(2): 80-88, 2022 04.
Статья в английский, испанский | MEDLINE | ID: covidwho-1766097

Реферат

INTRODUCTION: The current evidence indicates that the severity of the coronavirus disease 2019 (COVID-19) is lower in the pediatric population but local data are still limited. Objective: To characterize the clinical and epidemiological aspects of COVID-19 infection in patients younger than 18 years in Argentina. POPULATION AND METHODS: Cross-sectional, observational, and analytical study of confirmed COVID-19 patients aged 0-18 years seen between March 2020 and March 2021 at 19 referral children's hospitals of Argentina. A multivariate analysis was done to identify predictors of severe cases. RESULTS: A total of 2690 COVID-19 cases were included: 77.7% lived in the Metropolitan Area of Buenos Aires; 50.1% were males; patients' median age was 5.6 years. Of them, 90% were seen during epidemiological weeks 20-47 of 2020; 60.4% had a history of contact with COVID-19 patients; and 96.6% in their family setting. Also, 51.4% had respiratory symptoms; 61.6%, general symptoms; 18.8%, gastrointestinal symptoms; 17.1%, neurological symptoms; 7.2%, other symptoms; and 21.5% were asymptomatic. In addition, 59.4% of patients were hospitalized and 7.4% had a severe or critical course. A total of 57 patients developed multisystem inflammatory syndrome. A history of asthma, bronchopulmonary dysplasia, congenital heart disease, moderate to severe malnutrition, obesity, chronic neurological disease and/or age younger than 6 months were independent predictors of severity. Living in a vulnerable neighborhood was a protective factor. CONCLUSIONS: More than half of cases referred a history of contact with COVID-19 patients in the family setting. Hospitalization was not based on clinical criteria of severity. Severity was associated with the presence of certain comorbidities.


Introducción. La evidencia actual indica que la gravedad de la enfermedad por el coronavirus 2019 (COVID-19, por su sigla en inglés) es menor en la población pediátrica, los datos locales aún son limitados. OBJETIVO: caracterizar los aspectos clínicos y epidemiológicos de la infección por COVID-19 en menores de 18 años en Argentina. Población y métodos. Estudio transversal, observacional y analítico de casos confirmados de COVID-19 entre 0 y 18 años asistidos entre marzo de 2020 y marzo de 2021 en 19 centros pediátricos de referencia de Argentina. Se realizó un análisis multivariado para identificar las variables predictoras de cuadros graves. RESULTADOS: Se incluyeron 2690 casos de COVID-19: 77,7 % residentes del área metropolitana de Buenos Aires, 50,1 % de sexo masculino, mediana de edad de 5,6 años. El 90 % ocurrió entre las semanas epidemiológicas 2047 del 2020; 60,4 % con antecedente de contacto con personas con COVID-19; y 96,6 % en el entorno familiar. El 51,4 % presentó síntomas respiratorios; 61,6 % síntomas generales; 18,8 % síntomas gastrointestinales; 17,1 % síntomas neurológicos; 7,2 % otros y 21,5 % fueron asintomáticos. El 59,4 % fue hospitalizado; 7,4 % fueron graves o críticos. Se registraron 57 casos de síndrome inflamatorio multisistémico. El antecedente de asma, displasia broncopulmonar, cardiopatía congénita, desnutrición moderada a grave, obesidad, enfermedad neurológica crónica y/o edad menor de 6 meses resultaron predictores independientes de gravedad. Residir en barrios vulnerables resultó protector. CONCLUSIONES: Más de la mitad de los casos refirieron antecedente de contacto con personas con COVID-19 en el entorno familiar. La hospitalización no respondió a criterios clínicos de gravedad. La gravedad se encuentra asociada a la existencia de ciertas comorbilidades.


Тема - темы
COVID-19 , Adolescent , Argentina/epidemiology , COVID-19/complications , COVID-19/epidemiology , Child , Child, Preschool , Cross-Sectional Studies , Humans , Infant , Infant, Newborn , Male , Pandemics , Preliminary Data , Systemic Inflammatory Response Syndrome
6.
BMC Infect Dis ; 22(1): 120, 2022 Feb 04.
Статья в английский | MEDLINE | ID: covidwho-1690953

Реферат

BACKGROUND: COVID-19 pandemic is the major public health problem in the world actually. It's associated with high morbidity and mortality. To date, no therapeutic measure has a curative potential. Hydroxychloroquine (HCQ) is a drug with immunomodulatory properties that has demonstrated antiviral efficacy in in vitro experiments, with conflicting results in in vivo studies. METHODS: A single-center, prospective and interventional study, that evaluates the impact on mortality of the HCQ use in 154 patients hospitalized with COVID-19 in a Brazilian public hospital. The study also aims to determine prognostic factors that predict mortality, ICU admission and endotracheal intubation in this population. RESULTS: 154 patients diagnosed with COVID-19 confirmed by RT-PCR and hospitalized were included. There was a male predominance (87/154, 56.5%), median age 60 years and 88% (136/154) had comorbidities. Among these, 76% (117/154) were admitted to the ICU and 29.2% (45/154) experienced EOT. The OMR was 51.3% (79/154). There was no difference in mortality between patients treated with HCQ (N = 95) and non-HCQ (N = 59) (44.1% × 55.8%, p = 0.758). In univariate analysis, age ≥ 60 years (HR 3.62, p < 0.001), need for mechanical ventilation (HR 2.17, p = 0.001), ≥ 2 comorbidities (HR 1.83, p = 0.049), SAH (HR: 1.56, p = 0.054) were predictors of mortality, as well as no use of prophylactic or therapeutic heparin (HR 3.60, p = 0.02). Multivariate analysis identified admission to the ICU (HR 8.98, p = 0.002) and advanced age (HR 3.37, p < 0.01) as independent predictors of mortality, although, use of heparin (HR 0.25, p = 0.001) was independently associated with a favorable outcome. CONCLUSION: This study confirmed the absence of a benefit associated with the use of HCQ in Brazilian patients hospitalized with COVID-19. However, prophylactic or therapeutic heparin was an independent predictor for reducing mortality in this population.


Тема - темы
COVID-19 , Hydroxychloroquine , Antiviral Agents/therapeutic use , Brazil , COVID-19/drug therapy , Heparin/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Male , Middle Aged , Pandemics , Preliminary Data , Prospective Studies , SARS-CoV-2 , Treatment Outcome
7.
Opt Express ; 30(2): 1723-1736, 2022 Jan 17.
Статья в английский | MEDLINE | ID: covidwho-1636056

Реферат

We present an automated method for COVID-19 screening based on reconstructed phase profiles of red blood cells (RBCs) and a highly comparative time-series analysis (HCTSA). Video digital holographic data -was obtained using a compact, field-portable shearing microscope to capture the temporal fluctuations and spatio-temporal dynamics of live RBCs. After numerical reconstruction of the digital holographic data, the optical volume is calculated at each timeframe of the reconstructed data to produce a time-series signal for each cell in our dataset. Over 6000 features are extracted on the time-varying optical volume sequences using the HCTSA to quantify the spatio-temporal behavior of the RBCs, then a linear support vector machine is used for classification of individual RBCs. Human subjects are then classified for COVID-19 based on the consensus of their cells' classifications. The proposed method is tested on a dataset of 1472 RBCs from 24 human subjects (10 COVID-19 positive, 14 healthy) collected at UConn Health Center. Following a cross-validation procedure, our system achieves 82.13% accuracy, with 92.72% sensitivity, and 73.21% specificity (area under the receiver operating characteristic curve: 0.8357). Furthermore, the proposed system resulted in 21 out of 24 human subjects correctly labeled. To the best of our knowledge this is the first report of a highly comparative time-series analysis using digital holographic microscopy data.


Тема - темы
COVID-19/diagnostic imaging , Erythrocytes/classification , Holography/methods , Intravital Microscopy/methods , COVID-19/blood , Case-Control Studies , Equipment Design , Holography/instrumentation , Humans , Intravital Microscopy/instrumentation , Preliminary Data , ROC Curve , Sensitivity and Specificity
8.
J Clin Virol ; 146: 105057, 2022 01.
Статья в английский | MEDLINE | ID: covidwho-1638778

Реферат

It is well-known that the Coronavirus Disease 2019, which is caused by the beta-coronavirus severe acute respiratory syndrome (SARS-CoV-2), emerged in December 2019 followed by an outbreak first reported in Wuhan, China. Thus far, vaccination appears to be the only way to bring the pandemic to an end. In the present study, immunogenicity data was evaluated using LIAISON® SARS-CoV-2 TrimericS IgG assay (DiaSorin S.p.A) among a sample of 52 vaccinated healthcare workers, five of whom were previously infected with SARS-CoV-2 and 47 who were seronegative, over a time span of ≤90 days following the second dose of the BNT162b2 mRNA vaccine. The test detects antibodies against the Trimeric complex (S1, S2 and receptor binding domain). The overall mean value of the serum levels of IgG antibodies to SARS-CoV-2 30 days following the second dose of the vaccine was 1,901.8 binding arbitrary unit (BAU)/ml, after 60 days the mean value declined to 1,244.9 BAU/ml. The antibody levels then reached a plateau, as confirmed by the antibody test carried out 90 days following the second dose, which revealed a mean value of 1,032.4 BAU/ml (P<0.0001). A higher level was observed at all three times in male subjects compared with female subjects, and in younger male participants compared with female participants, although these differences did not reach a statistically significant level. Similarly, no significant difference was found in antibody values at different times according to age. After the second dose of the vaccine, two subjects were infected with SARS-CoV-2, and an increase in antibody values in the third assay was observed in both individuals.


Тема - темы
COVID-19 , Antibodies, Neutralizing , Antibodies, Viral , COVID-19 Vaccines , Female , Humans , Male , Preliminary Data , SARS-CoV-2 , Vaccines, Synthetic
9.
BMC Pregnancy Childbirth ; 21(1): 840, 2021 Dec 22.
Статья в английский | MEDLINE | ID: covidwho-1637767

Реферат

BACKGROUND: The COVID-19 pandemic poses an unprecedented risk to the global population. Maternity care in the UK was subject to many iterations of guidance on how best to reconfigure services to keep women, their families and babies, and healthcare professionals safe. Parents who experience a pregnancy loss or perinatal death require particular care and support. PUDDLES is an international collaboration investigating the experiences of recently bereaved parents who suffered a late miscarriage, stillbirth, or neonatal death during the global COVID-19 pandemic, in seven countries. In this study, we aim to present early findings from qualitative work undertaken with recently bereaved parents in the United Kingdom about how access to healthcare and support services was negotiated during the pandemic. METHODS: In-depth semi-structured interviews were undertaken with parents (N = 24) who had suffered a late miscarriage (n = 5; all mothers), stillbirth (n = 16; 13 mothers, 1 father, 1 joint interview involving both parents), or neonatal death (n = 3; all mothers). Data were analysed using a template analysis with the aim of investigating bereaved parents' access to services, care, and networks of support, during the pandemic after their bereavement. RESULTS: All parents had experience of utilising reconfigured maternity and/or neonatal, and bereavement care services during the pandemic. The themes utilised in the template analysis were: 1) The Shock & Confusion Associated with Necessary Restrictions to Daily Life; 2) Fragmented Care and Far Away Families; 3) Keeping Safe by Staying Away; and 4) Impersonal Care and Support Through a Screen. Results suggest access to maternity, neonatal, and bereavement care services were all significantly reduced, and parents' experiences were notably affected by service reconfigurations. CONCLUSIONS: Our findings, whilst preliminary, are important to document now, to help inform care and service provision as the pandemic continues and to provide learning for ongoing and future health system shocks. We draw conclusions on how to enable development of safe and appropriate services during this pandemic and any future health crises, to best support parents who experience a pregnancy loss or whose babies die.


Тема - темы
Abortion, Spontaneous/psychology , Bereavement , COVID-19/psychology , Grief , Parents/psychology , Perinatal Death , Stillbirth/psychology , Continuity of Patient Care/standards , Female , Health Services Accessibility/standards , Humans , Infant, Newborn , Male , Pregnancy , Preliminary Data , Psychosocial Support Systems , Qualitative Research , Quarantine/psychology , SARS-CoV-2 , United Kingdom/epidemiology
10.
PLoS One ; 16(3): e0248675, 2021.
Статья в английский | MEDLINE | ID: covidwho-1574573

Реферат

BACKGROUND: In December 2019, a new disease named coronavirus disease 2019 (COVID-19) was occurred. Patients who are critically ill with COVID-19 are more likely to die, especially elderly patients. We aimed to describe the effect of age on the clinical and immune characteristics of critically ill patients with COVID-19. METHODS: We retrospectively included 32 patients with COVID-19 who were confirmed to have COVID-19 by the local health authority and who were admitted to the first affiliated hospital of Zhengzhou University in Zhengzhou, China between January 3 and March 20, 2020. Clinical information and experimental test data were retrospectively collected for the patients. The 32 patients in this study were all in a critical condition and were classified as severe, according to the guidelines of 2019-nCoV infection from the National Health Commission of the People's Republic of China. Data were compared between those <60 years old and ≥60 years old. RESULTS: Of 32 patients, 13 were under 60 years old, and 19 patients were ≥60 years old. The most common symptom among all patients upon admission was fever (93.8%, 30/32). Compared to younger patients, older patients exhibited increased comorbidities. Among patients who were 60 years and older, platelet count, direct bilirubin (DBIL), indirect bilirubin(IBIL), lactate dehydrogenase (LDH), B-type natriuretic peptide (BNP), C-reactive protein (CRP), procalcitonin (PCT), and interleukin-10 (IL-10) were significantly higher than in younger patients who were less than 60 years old. CD4+ T lymphocytes, CD8+ T lymphocytes, and NKT lymphocytes were decreased, CD4+/CD8+ T lymphocytes were significantly increased in all 32 patients, while there were no evident differences between younger and older patients. The CURB-65 (confusion, urea, respiratory, rate, blood pressure plus age ≥65 years), Acute Physiology and Chronic Health Evaluation (APACHE) II and pH value were significantly higher in older patients than in patients who were under 60 years old. However, the PaO2 and PaO2:FiO2 were lower in older patients than the younger. Compared to patients under 60 years old, patients who were 60 years and older tended to develop ARDS (15 [78.9%] vs 5 [38.5%]), septic shock (7 [36.8%] vs 0 [0.0%]) and were more likely to receive mechanical ventilation (13 [68.4%] vs 3[23.1%]). Dynamic trajectories of seven laboratory parameters were tracked on days 1, 3, 5 and 7, and significant differences in lymphocyte count (P = 0.026), D-dimer (P = 0.010), lactate dehydrogenase (P = 0.000) and C-reactive protein (P = 0.000) were observed between the two age groups. CONCLUSIONS: A high proportion of critically ill patients were 60 or older. Furthermore, rapid disease progression was noted in elderly patients. Therefore, close monitoring and timely treatment should be performed in elderly COVID-19 patients.


Тема - темы
COVID-19/epidemiology , Age Factors , Aged , CD4-CD8 Ratio , COVID-19/blood , COVID-19/diagnosis , COVID-19/immunology , Critical Illness , Female , Humans , Immunity , Lymphocyte Count , Male , Middle Aged , Preliminary Data , Retrospective Studies , SARS-CoV-2/isolation & purification , Severity of Illness Index
12.
JAMA ; 326(16): 1606-1613, 2021 10 26.
Статья в английский | MEDLINE | ID: covidwho-1505020

Реферат

Importance: As part of postauthorization safety surveillance, the US Food and Drug Administration (FDA) has identified a potential safety concern for Guillain-Barré syndrome (GBS) following receipt of the Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccine. Objective: To assess reports of GBS received in the Vaccine Adverse Event Reporting System (VAERS) following Ad26.COV2.S vaccination. Design, Setting, and Participants: Reports of presumptive GBS were identified in a US passive reporting system (VAERS) February-July 2021 and characterized, including demographics, clinical characteristics, and relevant medical history. Exposures: Receipt of the Ad26.COV2.S vaccine; the comparator was the background rate of GBS in the general (unvaccinated) population that had been estimated and published based on a standardized case definition. Main Outcomes and Measures: Presumptive GBS; the reporting rate was analyzed, including calculation of the observed to expected ratio based on background rates and vaccine administration data. Because of limited availability of medical records, cases were not assessed according to the Brighton Collaboration criteria for GBS. Results: As of July 24, 2021, 130 reports of presumptive GBS were identified in VAERS following Ad26.COV2.S vaccination (median age, 56 years; IQR, 45-62 years; 111 individuals [86.0%] were < 65 years; 77 men [59.7%]). The median time to onset of GBS following vaccination was 13 days (IQR, 10-18 days), with 105 cases (81.4%) beginning within 21 days and 123 (95.3%) within 42 days. One hundred twenty-one reports (93.1%) were serious, including 1 death. With approximately 13 209 858 doses of vaccine administered to adults in the US, the estimated crude reporting rate was 1 case of GBS per 100 000 doses administered. The overall estimated observed to expected rate ratio was 4.18 (95% CI, 3.47-4.98) for the 42-day window, and in the worst-case scenario analysis for adults 18 years or older, corresponded to an estimated absolute rate increase of 6.36 per 100 000 person-years (based on a rate of approximately 8.36 cases per 100 000 person-years [123 cases per 1 472 162 person-years] compared with a background rate of approximately 2 cases per 100 000 person-years). For both risk windows, the observed to expected rate ratio was elevated in all age groups except individuals aged 18 through 29 years. Conclusions and Relevance: These findings suggest a potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt of the Ad26.COV2.S vaccine. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis.


Тема - темы
COVID-19 Vaccines/adverse effects , Guillain-Barre Syndrome/epidemiology , Adult , Age Distribution , Aged , COVID-19 Vaccines/administration & dosage , Female , Guillain-Barre Syndrome/etiology , Humans , Male , Middle Aged , Preliminary Data , Product Surveillance, Postmarketing , United States/epidemiology , Vaccination/statistics & numerical data , Young Adult
13.
Acta Biomed ; 92(S6): e2021441, 2021 10 19.
Статья в английский | MEDLINE | ID: covidwho-1504330

Реферат

The direct and indirect stressful effects of COVID-19 lockdown measures adopted to restrict population movements to help curb the epidemic impacted on people's daily lives. Biella is a small Northern Italy province, historically characterized by the presence of an important and once flourishing textile industry. For decades this province has had suicide rates higher than the Piedmonts and Italian average. In two most recent decades a positive correlation between financial stressors, 2008 economic crisis related, and suicide has been found. As the current economic crisis COVID-19 related is expected to exacerbate again the vulnerability to suicide of this province, during the first lockdown the Crisis Center for Suicide Prevention of Biella set up a telephone counselling service. We aimed to evaluate whether it represented a suitable and useful tool for suicidal crisis prevention. Each phone intervention consisted of four phases: (i) psychoeducation, (ii) emotional stabilization, (iii) personal resources identification/reinforcement, (iv) session ending. This service provided a rapid therapeutic response to urgent requests for care, psychological support, and reassurance. It was able to mitigate stress and reinforce resilience in particularly vulnerable populations. The most innovative element of this project was that it proposed interventions for the emotional stabilization, something that is usually used in face-to-face sessions. Using the right protocols, it proved to offer continuity care and reduce pressure on hospital emergency departments while delivering good outcomes and patient satisfaction. Therefore, the COVID-19 pandemic provided an opportunity to overcome normative, technological, and cultural barriers regarding the use of remote healthcare services.


Тема - темы
COVID-19 , Pandemics , Adaptation, Psychological , Communicable Disease Control , Counseling , Humans , Preliminary Data , SARS-CoV-2 , Telephone
14.
Neurol Sci ; 43(1): 51-58, 2022 Jan.
Статья в английский | MEDLINE | ID: covidwho-1465874

Реферат

Psychological, emotional, and behavioral domains could be altered in COVID-19 patients and measurement of variables within these domains seems to be mandatory. Neuropsychological assessment could detect possible cognitive impairment caused by COVID-19 and the choice of appropriate tools is an important question. Aim of this exploratory study was to verify the effectiveness of an assessment model for patients with COVID-19. Twelve patients were enrolled and tested with Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Anxiety and Depression Short Scale (AD-R), and the Neuropsychiatry Inventory (NPI), at the time of their entrance (T0) and discharge (T1) from a rehabilitative unit. Moreover, a follow-up evaluation after 3 months (T2) has been conducted on eight patients. Results showed that at baseline (T0), 58.3% of the patients reported a score below cut-off at MMSE and 50% at MoCA. Although a significant amelioration was found only in NPI scores, a qualitative improvement has been detected at all tests, except for MoCA scores, in the T0-T1 trend analysis. A one-way repeated measures analysis of variance showed a significant variation in AD-R depression score, considering the three-assessment time (T0, T1, and T2). The evaluation and tracking over time of the impact of COVID-19 on cognitive, psychological, and behavioral domains has relevant implications for rehabilitation and long-term assistance needs planning. The choice of assessment tools should consider patients vulnerability and match the best compromise among briefness, sensitivity, and specificity.


Тема - темы
COVID-19 , Cognitive Dysfunction , Cognition , Cognitive Dysfunction/diagnosis , Cognitive Dysfunction/etiology , Humans , Mental Status and Dementia Tests , Neuropsychological Tests , Preliminary Data , SARS-CoV-2
15.
Nat Med ; 27(11): 2025-2031, 2021 11.
Статья в английский | MEDLINE | ID: covidwho-1412033

Реферат

The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.


Тема - темы
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunization, Secondary , Immunogenicity, Vaccine , SARS-CoV-2/immunology , Adult , Aged , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19/immunology , COVID-19 Vaccines/adverse effects , Female , Healthy Volunteers , Humans , Immunization, Secondary/adverse effects , Male , Middle Aged , Preliminary Data , RNA, Messenger/adverse effects , RNA, Messenger/genetics , RNA, Messenger/immunology , SARS-CoV-2/genetics , Treatment Outcome , United States , Vaccination/adverse effects
20.
Eur J Cancer ; 154: 246-252, 2021 09.
Статья в английский | MEDLINE | ID: covidwho-1333382

Реферат

BACKGROUND: Specific data regarding coronavirus disease 2019 (COVID-19) in patients with neuroendocrine neoplasms (NENs) are lacking. The aim of this study is to describe the characteristics of patients with NENs who tested severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive. MATERIAL AND METHODS: This is a worldwide study collecting cases of patients with NENs along with a positive nasopharyngeal swab reverse transcriptase-polymerase chain reaction (RT-PCR) test for SARS-CoV-2 between June 1, 2020, and March 31, 2021. Centres treating patients with NENs were directly contacted by the principal investigator. Patients with NENs of any primary site, grade and stage were included, excluding small-cell lung carcinoma and mixed adenoneuroendocrine carcinoma. RESULTS: Among 81 centres directly contacted, 88.8% responded and 48.6% of them declined due to lack of cases or interest. On March 31st, 2021, eight recruiting centres enrolled 89 patients. The median age was 64 years at the time of COVID-19 diagnosis. Most patients had metastatic, non-functioning, low-/intermediate-grade gastroenteropancreatic NENs on treatment with somatostatin analogues and radioligand therapy. Most of them had comorbidities. Only 8% of patients had high-grade NENs and 12% were receiving chemotherapy. Most patients had symptoms or signs of COVID-19, mainly fever and cough. Only 3 patients underwent sub-intensive treatment, whereas most of them received medical therapies, mostly antibiotics. In two third of cases, no changes occurred for the anti-NEN therapy. More than 80% of patients completely recovered without sequelae, whereas 7.8% patients died due to COVID-19. CONCLUSIONS: Patients included in this study reflect the typical NEN population regardless of SARS-CoV-2. In most cases, they overcome COVID-19 without need of intensive care, short-term sequelae and discontinuation of systemic oncological therapy.


Тема - темы
COVID-19/therapy , Carcinoma, Neuroendocrine/therapy , Global Health , Adult , Aged , COVID-19/diagnosis , COVID-19/immunology , COVID-19/virology , Carcinoma, Neuroendocrine/diagnosis , Carcinoma, Neuroendocrine/immunology , Comorbidity , Female , Humans , Male , Middle Aged , Preliminary Data , Prospective Studies , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Young Adult
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